Double-blind randomized comparison of efficacy and side effects of Bupropion versus methyl phenidate in children with Attention Deficit Hyperactivity Disorder (ADHD)
The overall goals: Comparison of efficacy and side effects of Bupropion versus Methylphenidate in Children with Attention Deficit Hyperactivity Disorder (ADHD). Study design: Double-Blind. Inclusion criteria:1- Children 6 to 12 years old Diagnosed With ADHD based on DSM-IV-TR; 2- Not having Medical Problems Including a history of Epilepsy; 3– Not having the history of taking Bupropion or Methylphenidate; 4- not taking other psychiatric drugs. Exclusion criteria: 1- Not wanting parents to complete research Projects; 2- Having serious complications such as epilepsy. Sample size: 40. Methods of execution and interventions: 40 Children with ADHD (Referred to Ibne-sina child psychiatrist clinic) who have the inclusion criteria are selected through available consecutive sampling and will be assigned randomly to treatment with Methylphenidate and Bupropion. Children will be assessed with ADHD-RS (Teacher and Parent) and C-GAS, at Baseline then after 4 and 8 weeks of treatment. Dosing range is 0.3 to 0.8 mg/kg for Methylphenidate and 3-6 mg/kg for Bupropion. Primary outcomes: 1- ADHD–RS. 2- C-GAS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012295500N1
Registration date:2012-03-29, 1391/01/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-29, 1391/01/10
Registrant information
Name
Mohsen Pasandideh
Name of organization / entity
Ibn-e-sina hospital, Mashad university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 57 1226 5016
Email address
pasandidem821@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice chancellor of Mashad university of medical sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-06-21, 1390/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double-blind randomized comparison of efficacy and side effects of Bupropion versus methyl phenidate in children with Attention Deficit Hyperactivity Disorder (ADHD)
Public title
Comparison of effect of methyl phenidate (Ritalin) and bupropion in children with hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-Children 6 to 12 years old with diagnosis of ADHD on the basis of DSM-IV-TR; 2-children without MR (IQ>70); 3-children without medical and neurologic problems specially with a history of epilepsy; 4-children without eating disorders (because of being prone to seizure due to bupropion); 5-agreement of parents in research participation; 6-the child that does not have the history of using Methyl phenidate and Bupropion and other psychiatric drugs. Exclusion criteria: 1-disagreement of parents during the research; 2-existance of severe side effects like neurologic disorders such as convulsion in curing groups.
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashad university of medical sciences
Street address
Central departement of Mashad university of medical sciences, Daneshgah street
City
Mashad
Postal code
91388-13944
Approval date
2009-12-15, 1388/09/24
Ethics committee reference number
6543
Health conditions studied
1
Description of health condition studied
attention deficit hyperactivity disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
Assessment of children (C-GAS)
Timepoint
Before intervention, the fourth week and eighth week after the start of intervention
Method of measurement
Teacher and parent questionnaire
2
Description
Attention Deficit, hyperactivity Disorder Scale
Timepoint
Before intervention, the fourth week and eighth week after the start of intervention
Method of measurement
Teacher and parent questionnaire
Secondary outcomes
1
Description
Side effects of bupropion
Timepoint
the fourth week and eighth week after the start of intervention
Method of measurement
Questionnaire check list
2
Description
Side effects of stimulant drugs
Timepoint
the fourth week and eighth week after the start of intervention
Method of measurement
Questionnaire check list
Intervention groups
1
Description
Bupropion, 75 milligram tablets, orally, two times a day, Morning and afternoon
Category
Treatment - Drugs
2
Description
Methylphenidate (Ritalin) tablets, 10 mg, orally, two times a day, morning and evening, based on weight 0.3-0.8 mg/kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Special clinic of Ebn-e-Sina Psychiatry Hospital
Full name of responsible person
Atefeh Soltanifar, MD, Subspecialist of childs and adolescents psychiatry
Street address
Ibn-e-Sina Hospital, Horeameli Avenue
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research vice chancellor of Mashad university of medical sciences
Full name of responsible person
Mrs. Ardekanian
Street address
Research vice chancellor, Ghoreshi departement, Danshgah street
City
Mashad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice chancellor of Mashad university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashad university of medical sciences
Full name of responsible person
Mohsen Pasandideh
Position
Intern
Other areas of specialty/work
Street address
Ibn-e-Sina Hospital, Horeameli Avenue
City
Mashad
Postal code
Phone
+98 51171127019
Fax
+98 51 1711 2545
Email
pasandidem821@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashad university of medical sciences
Full name of responsible person
Dr. Atefeh Soltanifar
Position
Subspecialist of childs and adolescents psychiatry